BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR WIRE STRAIGHT TIP

    MDR report key: 2728886 · Received June 25, 2012

    Report

    Report Number
    2728886
    Event Type
    Injury
    Date Received
    June 25, 2012
    Date of Event
    June 14, 2012
    Report Date
    June 20, 2012
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PLASTIC COVERING OF WIRE BROKE AND REMAINS IN THE KIDNEY. WILL NEED TO BE REMOVED AT A FUTURE PROCEDURE E.Q. PERCUTANEOUS NEPHROLITHOTRIPSY OR OPEN PYELOLITHOTOMY. SEE SCANNED PAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSOR WIRE STRAIGHT TIP NONE DQX BOSTON SCIENTIFIC 13941804

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention